Method and measuring system for continuously determining the intra-arterial blood pressure

ABSTRACT

The invention describes a measuring system for the continuous non-invasive determination of blood pressure at one or more fingers. The fingers chosen for measurement and the adjacent parts of the palm rest on a supporting surface of a housing, which has the shape of a computer mouse. Inside the housing of the “CNAP Mouse”, i.e. underneath the supporting surface for the hand, the pressure generating system is located. The finger sensors are mounted on the supporting surface for the hand. The forearm and the back of the hand are left free and may be used to place intra-venous or intra-arterial access elements. Since the hand will rest on the supporting surface motion artefacts are largely avoided. Tilting or turning of the sensors is hardly possible since the fit of the sensors and thus the coupling of light and pressure are optimized.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. application Ser. No.16/078,743, filed Nov. 7, 2018, which is a U.S. National PhaseApplication pursuant to 35 U.S.C. § 371 of International Application No.PCT/AT2016/050035 filed Feb. 22, 2016. The entire disclosure content ofthis application is herewith incorporated by reference into the presentapplication.

BACKGROUND

The invention relates to a method and a measuring system forcontinuously determining the intra-arterial blood pressure at one ormore fingers of a hand by means of a finger sensor. The sensor comprisesa plethysmographic system with at least one light source, at least onelight receiver or light detector, and at least one inflatable cuff.Further there is provided a pressure generating system with at least onevalve, which is controlled in real time by the plethysmographic systemfor generating pressure in the cuff, the pressure essentiallycorresponding to the intra-arterial blood pressure in the finger.

Continuous non-invasive measurement of blood pressure presents eventoday a serious challenge to measuring technology. The so-called“Vascular Unloading Technique” is beginning to dominate the market. Thistechnique is based on a publication by Penáz (Digest of the 10thInternational Conference on Medical and Biological Engineering, 1973Dresden) and has been improved by diverse enhancements.

The Vascular Unloading Technique begins with shining light through afinger, thus determining the pulsatile (pulse-shaped) blood flow in thefinger. This method is called photo-plethysmography (PPG) and is usuallyimplemented with the use of one or more light-emitting diodes (LEDs)working at one or more wavelengths, and one or more light-sensitivereceiving diodes (photo diodes).

A control system keeps the registered flow and thus the resulting PPGsignal (volume signal v(t)) constant by applying counter pressure in acuff (cuff pressure p_(c)(t)) around the finger. This counter pressurep_(c)(t) is generated via a fast valve or valve system fed by a pump.The valve or valve system is controlled by the control unit, whichpreferably is realized as a microcomputer. The essential input signal isthe PPG signal v(t), in more recent control systems the cuff pressurep_(c)(t) is used as an additional input variable. The pressure p_(c)(t)necessary to keep the flow or rather the PPG signal v(t) constant thuscorresponds to the intra-arterial blood pressure p_(a)(t).

In order to fulfill the real-time condition it is necessary that thecuff pressure p_(c)(t) can be varied at least as fast as theintra-arterial blood pressure p_(a)(t) changes. For complete fulfillmentof this control condition the cuff pressure p_(c)(t) must be able tomimic the intra-arterial pressure p_(a)(t) in the time domain as well asin the frequency domain. The upper frequency limit of p_(a)(t) and thusthe highest rate of change of the pressure lies upwards of at least 20Hz, presenting a serious challenge for the pressure system. As aconsequence pressure generation via a valve or valve system must belocated in the immediate vicinity of the cuff. If long air tubes areused the frequency limit condition cannot be met due to the low-passcharacteristic of the tubes. In all known devices commercially availableor described in publications, the valve or valve system or pressuregenerating system is therefore located on the distal forearm next to thewrist, either on the upper side or underside of the arm.

Placing the pressure generating system on the distal forearm next to thewrist has serious disadvantages: this site is often chosen forintravenous access points and intra-arterial access should also bepossible at the distal end of radius in cases of emergency. These accesspoints would be blocked by the pressure generating system and itsfastening elements. The system might also slip or tilt during operation.This might have an adverse effect on the positioning of the sensors.Positioning of the sensors would moreover be improved if the finger tobe measured or the corresponding hand could be held in a state of rest.

A large number of publications concerning the Vascular UnloadingTechnique are known: U.S. Pat. No. 4,406,289 (Wesseling et al.)describes a mechanical valve which generates the counter pressure in thefinger cuff with desired accuracy if fed by a linear pump. The valve isplaced in a housing at the distal forearm and supplies pressure p_(c)(t)to the finger cuff via a short tube.

U.S. Pat. No. 4,524,777 (Kisioka et al.) describes a pressure generatingsystem for the Vascular Unloading Technique. A constant cuff pressureP_(c) is first generated by a linear pump on which pressure fluctuationsΔp_(c)(t) are superimposed, which are supplied by a “shaker” or “drivingactuator” connected in parallel.

U.S. Pat. No. 4,726,382 (Boehmer et al.) describes a finger cuff for theVascular Unloading Technique, which has tube fittings for supplying thecuff pressure p_(c)(t). The length of the tubes is sufficient to reachthe pressure generation system (not shown) placed on the distal forearm.

WO 2000/059369 (Fortin et al.) also describes a pressure generatingsystem for the Vascular Unloading Technique. The valve system consistsof a separate inlet and a separate outlet valve. While U.S. Pat. Nos.4,406,289 and 4,524,777 require a relatively linear proportional pump,this system permits the use of simple, less costly pumps, since noxiousharmonics are eliminated due to the arrangement of the valves.Furthermore the energy required for the simple pump is substantiallyreduced due to the valve principle.

WO 2004/086963 (Skrabal et al.) describes a system for the VascularUnloading Technique, in which blood pressure can be continuouslymeasured in one finger, while the adjacent finger (“Watch Dog”) is usedfor quality control. After a certain time the system automaticallyexchanges the “measurement finger” and the “supervisor finger”.

WO 2005/037097 (Fortin et al.) describes a control system for theVascular Unloading Technique, in which a plurality of nested controlloops provide for high frequency pressure variation and long timestability of accuracy.

WO 2010/050798 (Guelen et al.) essentially describes a pressuregeneration system attached to the distal forearm (“Frontend”) with onlyone valve that can be connected to a finger cuff for the VascularUnloading Technique.

WO 2011/045138 (Langewouters et al.) describes a pressure generationsystem for the Vascular Unloading Technique, where—similar to WO2000/059369—energy consumption of the pump is reduced and harmonics areeliminated.

WO 2011/051819 (Fortin et al.) describes a novel kind of VascularUnloading Technique entirely implemented by digital electronics, withimproved stability and further miniaturization.

WO 2011/051822 (Fortin et al.) describes a method for the VascularUnloading Technique, in which the measured signals v(t) and p_(c)(t) areprocessed such that long term stability is improved and furtherhemodynamic parameters can be obtained. In particular, a method foreliminating vasomotoric fluctuations of the finger arteries and a methodfor determining the cardiac output are described.

WO 2012/032413 (Huber et al.) describes a novel kind of finger sensorswith a disposable part.

SUMMARY

It is the object of the present invention, given a measuring system forcontinuous non-invasive determination of intra-arterial blood pressureas initially described, to propose improvements enhancing the patient'swearing comfort and to avoid tiring hand positions during lengthymeasurement periods.

According to the invention this object is achieved by providing that themeasuring system has a housing with a surface which may serve as asupporting surface for the at least one finger and adjacent parts of thepalm. Preferably the housing of the measuring system should essentiallyhave the dimensions and the outer shape of a computer mouse, with the atleast one finger sensor projecting from the supporting surface for thehand.

A measuring method according to the invention using a plethysmographicsystem and a pressure generating system controlled by theplethysmographic system, is characterized in that the finger or fingerschosen for measurement are introduced into the inflatable cuff and, toease tension in the hand, are placed on a supporting surface of ahousing together with adjacent parts of the palm, which housing containsthe pressure generating system.

The present invention combines the finger sensor, i.e. the finger cuffand its light generating system, and the pressure generating system,thereby avoiding the disadvantages cited above. The fingers chosen formeasurement and the respective hand rest on a supporting surface beneathwhich the pressure generating system is located. One or more fingersensors, i.e. the finger cuffs including the PPG system, are disposed onthe supporting surface for the hand. The forearm and the back of thehand are free and thus available for intra-venous or intra-arterialaccess points. Since both the fingers used for measurement and the handrest on the supporting surface, artefacts due to motion are reduced.Turning or tilting of the sensors is hardly possible as the positioningof the sensors and thus the coupling of light and pressure areoptimized.

Since the hand will rest on the supporting surface like on a computermouse, the system is called CNAP Mouse (Continuous Non-invasive ArterialPressure). The body or the housing of the “mouse” contains at least thepressure generating system for the Vascular Unloading Technique. The“ears” of the CNAP mouse are represented by the usually two fingersensors (cuffs including the PPG system). Two finger sensors are used topermit a longer period of measurement by interchanging the role of thefingers; while one finger is used for measuring continuous bloodpressure, the other finger is at rest. The CNAP mouse of course alsoworks with only one “ear”, i.e. with only one finger sensor.

The invention will now be described in more detail, with reference toschematically presented exemplary embodiments.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 shows a state-of-the-art measuring system, where the pressuregenerating system is placed at the distal end of the forearm;

FIG. 2 shows the measuring system according to the invention in theshape of a computer mouse (CNAP mouse) in a three-dimensional view;

FIG. 3 shows the measuring system of FIG. 2 in an exploded view;

FIG. 4 shows the measuring system of FIG. 2 with the cuff part removedand the PPG elements visible;

FIG. 5 shows the symmetrical design of the measuring system of FIG. 2 ina top view;

FIG. 6 shows all possible ways of applying the measuring system to theright or left hand of a patient; and

FIG. 7 shows a variant of the measuring system according to theinvention in an exploded view.

DETAILED DESCRIPTION

The invention describes a measuring system for the continuousnon-invasive determination of blood pressure. The combination ofpressure generating system and finger sensors comprising cuff and lightsystem—the photoplethysmographic system-is presented in detail.

In principle the Vascular Unloading Technique mimics the intra-arterialpressure in the finger cuff in real time. This is done by means of acontrol system which requires as input signal at least the light signalv(t) of the PPG system. More recent control systems, such as describedin publications WO 2000/059369, WO 2005/037097, WO 2011/0511819 or WO2011/051822, also use the cuff pressure p_(c)(t) as an input variable.

The pressures obey the following equation, which arises when theair-filled cuff is applied:

p _(c)(t)=p _(a)(t)−p _(t)(t)  (1)

where p_(t)(t) is the socalled “transmural pressure”, i.e. the pressuredifference between cuff pressure p_(c)(t) and intra-arterial bloodpressure p_(a)(t).

The transmural pressure p_(t)(t) acts on the diameter of the artery,which diameter can indirectly be determined from the PPG signal orvolume signal v(t). As has been described above, the control system willadapt the cuff pressure p_(c)(t) in real time such that v(t) will bekept constant, i.e. that Δv(t)=0. If this condition Δv(t)=0 isfulfilled, the transmural pressure p_(t)(t)=0, and therefore one has

p _(c)(t)=p _(a)(t)−0  (2)

In order to fulfil this real-time condition, the measuring system mustbe able to follow the changes in intra-arterial blood pressure p_(a)(t).Interpreting the control condition in the frequency domain the measuringsystem must be able to mimic pressure changes which transcend the upperlimit frequency of intra-arterial blood pressure. This upper limitfrequency of intra-arterial blood pressure p_(a)(t) lies approximatelyat 20 Hz.

All the methods and devices described require that the cuff pressurep_(c)(t) must be available over the total relevant frequency range withan upper limit frequency of at least 20 Hz, a requirement which presentsa challenge to the pressure generating system and its valves or valvesystem. It is therefore important that the pressure generating systemand its valve or valve system be situated in the immediate vicinity ofthe finger cuff. Depending on the rigidity of the connecting tube, themaximum distance will be 30 to 50 cm.

FIG. 1 shows how the pressure system 101 is connected to the fingersensor 102 in a state-of-the-art measuring system. The finger sensor 102shown is designed as a double finger sensor for index and middle finger100 of the right hand, permitting longer duration of measurement. Thefinger sensor 102 is supplied with pressure and electric energy via adouble tube system 103. The pressure system 101 is attached to thedistal end of the forearm by means of a fastening element 104 and issupplied via a cable 105 with electric energy and with basic pressure.

FIG. 2 shows the measuring system according to the invention, theassembled CNAP mouse. On the body or on the housing 1 of the CNAP mousethere is provided a relatively large supporting surface 11 upon whichthe hand may rest during the measuring operation. The finger sensors 2are attached to the housing 1. In the example there is shown a doublefinger sensor, with which each finger may be measured alternatingly. Thedouble sensor has two light sources (LEDs) 21 a, 21 b and at least twolight sensors 22 a, 22 b (partly visible). The two inflatable cuffs 23 aand 23 b are disposed on the interior areas 23 of the finger sensors 2.The part of the finger sensor 2 which carries the inflatable cuffs 23 a,23 b is removable and may be exchanged, and is attached to a lockingelement on the housing 1 by means of snap-on element 24.

FIG. 3 shows an exploded view of the CNAP mouse. First it is shown howthe pressure generating system 12 is integrated into the body or thehousing 1 of the mouse underneath the supporting surface 11 for thehand. In this case the pressure generating system 12 consists of anelectronic circuit board 12 a, which carries one or more valves 13 a, 13b as well as the elements of the valve control electronics. Preferably,a connector 14 is also provided on the board 12 a. The pressuregenerating system 12 is placed in the housing 1 and secured by a cover15 on the bottom of the housing 1. A cable 16 supplies the pressuregenerating system 12 with basic pressure, electric energy and thesignals emitted by the control system for the Vascular UnloadingTechnique.

On the top face of the housing 1 there are provided fittings for one ormore finger sensors. On the one hand these must have electric connectorsfor the PPG signal, on the other hand there must be provided pressurefittings for supplying pressure to the one or more cuffs. In the variantshown, which presents the double finger system as described above, thisis achieved as follows: a receiving slot 17 partitions the top of thebody of the mouse 1, which is also the supporting surface 11, into twopartial surfaces 11 a and 11 b. Into this slot two outer slideableelements 21 and a central element 22 are inserted. The slideableelements 21 contain the two LEDs 21 a and 21 b necessary for generatingthe PPG signal. The outer elements are movable in order to accommodatevarious sizes of the finger sensor. The element 22 sits in the middle ofthe slot and is not movable. It contains the two light detectors 22 aand 22 b.

Onto this body or housing 1 of the mouse carrying the elements 21, 22for the PPG signal as shown, the detachable part of the finger sensor 2may be mounted. The finger sensors may have diverse sizes or diameters.The optimum fit of the sensors may thus be adapted to the actual fingersize. The sensors have an air-inflatable cuff 23 a, 23 b whose pressurecan be controlled by the pressure generating system 12 with the requiredaccuracy. For this purpose fitting elements are provided, which areintegrated in the element 22 (not explicitly shown). Furthermore the PPGsystem must be integrated into the sensors. In the case shown this isrealized by the double finger sensor 2 already known. The double fingersensor 2 contains on its interior wall 23 a cuff 23 a, 23 b for eachfinger. The advantage of the design of the invention lies in the factthat no electrical leads for the PPG system are necessary for thedetachable part of the double finger sensor 2 containing the cuffs 23 a,23 b. The PPG elements sit on the housing 1 of the mouse and aresupplied with electrical power there.

FIG. 4 shows how the PPG elements 21 a, 21 b and 22 a, 22 b are attachedto the housing 1 of the mouse. One can see that the LED elements 21 a,21 b are movable in order to adapt to the detachable part of fingersensors of varying size. The element 22 carrying the light detectors 22a, 22 b, however, is fixedly attached in the middle of the supportingsurface 11. In this variant the connector 14 supplies the CNAP mousewith basic air pressure, electrical energy and control signals.

FIG. 5 shows a mirror-symmetrical variant of the invention in a topview. On the housing 1 of the CNAP mouse the finger sensor 2 isattached, which partitions the supporting surface 11 for the hand intotwo partial surfaces 11 a and 11 b. The CNAP mouse is supplied via acable 16 with basic air pressure, electrical energy and the controlsignals from below (as shown) or proximally as regards the hand. Thereis no problem in turning the mouse around and supplying it from above ordistally as regards the hand.

FIG. 6 demonstrates the advantage derived from the mirror-symmetricaldesign of the CNAP mouse. The mouse may be used with the fingers of theleft hand as well as with those of the right hand. The pair indexfinger, middle finger (as shown) may be used, as well as the pair middlefinger, third finger (not shown). The mouse may be served by the cable16 either from behind (proximally as regards the hand) or from in front(distally as regards the hand). This will afford maximum flexibility ofapplication of the device on the patient.

The supporting surface for the hand should preferably be soft,permitting hand and fingers to relax in order to avoid motion artefacts.A cushion or a gel pack may therefore be placed on the supportingsurface 11.

It is furthermore of advantage if the control system 3 with themicrocontroller 31 for fulfilling the real-time condition of theVascular Unloading Technique is also included in the housing 1 of theCNAP mouse (see FIG. 7). The electronic circuit board of the controlsystem 3 may for instance be disposed underneath the pressure generatingsystem 12. As a result the measuring system need only be supplied withbasic pressure and electrical energy.

Carrying this one step farther, it is also possible to integrate aminiature pump 33 in the housing 1 of the mouse. Between the pump 33 andthe pressure generating system 12 there is usually an air reservoir 34disposed, in order to compensate high frequency pressure fluctuationsresulting from irregularities in the pump motor. According to onevariant this small air reservoir 34 may also be integrated in the bodyof the mouse (see FIG. 7).

According to a variant of the invention space may be saved in thehousing 1 of the mouse by creating an airtight cavity underneath thesupporting surface for the hand which can serve as an air reservoir. Theelectronic circuit board will then be contained in the housing underincreased air pressure, but this will not harm the electronic circuits.The air reservoir will thus not require extra volume. In this case themeasuring system only has to be supplied with electrical energy.

As a further step of development a power pack or battery 35 may beintegrated into the housing 1. Using wireless signal transmission via awireless chip (see element 32 “wireless” in FIG. 7) the measuring systemmay function completely independently.

According to the invention it is also possible to attach only a singlefinger sensor in a corresponding slot on the CNAP mouse, but twoindividual finger sensors or more would be possible as well. The variantshown in the drawings seems to be of special practical use since thedouble finger system will permit long measuring times by alternatinglymeasuring one and the other finger.

The variants cited should be taken as examples only; any variantsresulting from permutations of these will also be considered protected.

1. A measuring system for the continuous determination of intra-arterialblood pressure at two fingers of a hand having a palm, the measuringsystem comprising: a double-finger sensor having inflatable cuffs forthe two fingers; a plethysmographic system comprising: at least twolight sources, with one or more wavelengths, and at least two lightdetectors; and a pressure generating system comprising: at least onevalve, controlled in real time by the plethysmographic system, forgenerating pressure in the cuffs, which pressure is available over afrequency range with an upper limit frequency of at least 20 Hz andcorresponds to the intra-arterial blood pressure in the finger; whereinthe measuring system has a housing comprising: an upper supportingsurface configured to support the two fingers and adjacent areas of thepalm of the hand, the upper supporting surface having a curved outerprofile; and a flat bottom surface configured to rest on a supportingplane; wherein the double-finger sensor projects from the uppersupporting surface; wherein a part of the double-finger sensor whichaccommodates the inflatable cuffs is fastened in a removable andexchangeable manner; and wherein the pressure generating system with theat least one controlled valve is located in the housing underneath thesupporting surface for the hand.
 2. The measuring system according toclaim 1, wherein on the upper supporting surface of the housing there isprovided a receiving slot, which partitions the supporting surfacemirror-symmetrically into two partial surfaces and contains elements forconnecting the plethysmo-graphic system to the double-finger sensor. 3.The measuring system according to claim 2, wherein two outer elementsare disposed in the receiving slot of the housing so as to be slideablein the direction of a central element, on which elements a part of thedouble-finger sensor holding the inflatable cuffs is detachably mounted.4. The measuring system according to claim 3, wherein the two outerelements contain the two light sources while the central elementcontains the two light detectors.
 5. The measuring system according toclaim 1, wherein a control system is disposed in the housing underneaththe upper supporting surface for the hand.
 6. The measuring systemaccording to claim 1, wherein a pump and an air reservoir are disposedin the housing underneath the upper supporting surface for the hand. 7.The measuring system according to claim 1, wherein the housing of themeasuring system is made air-tight underneath the upper supportingsurface for the hand, and acts as an air reservoir.
 8. The measuringsystem according to claim 1, wherein a battery or a power pack, andelements for wireless transmission of signals are disposed in thehousing underneath the upper supporting surface for the hand.